Cleared Traditional

Elecsys Cortisol III

K242505 · Roche Diagnostics · Chemistry
Jul 2025
Decision
329d
Days
Class 2
Risk

About This 510(k) Submission

K242505 is an FDA 510(k) clearance for the Elecsys Cortisol III, a Fluorometric, Cortisol (Class II — Special Controls, product code JFT), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on July 17, 2025, 329 days after receiving the submission on August 22, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K242505 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2024
Decision Date July 17, 2025
Days to Decision 329 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFT — Fluorometric, Cortisol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1205

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